Clinical trial of a topical emulgel containing piroxicam-entrapped nanoniosomes in patients with osteoarthritis or rheumatoid arthritis complaining joint pain

Start Date20 Feb 2024

Sponsor / Collaborator-

IRCT20230202057310N4 / RecruitingPhase 1/2

Comparative Analysis of Piroxicam and Post-isometric Exercises in Improving Knee Osteoarthritis

Start Date12 Sep 2023

Sponsor / Collaborator-

IRCT20230515058198N1 / SuspendedNot ApplicableIIT

Investigation of the effect of mesotherapy with piroxicam in the treatment of tennis elbow in comparison with oral medical therapy in terms of improving pain and function

Start Date01 Aug 2023

Sponsor / Collaborator

Shiraz University of Medical Sciences

100 Clinical Results associated with Piroxicam

100 Translational Medicine associated with Piroxicam

100 Patents (Medical) associated with Piroxicam

3,092

Literatures (Medical) associated with Piroxicam

01 Jun 2024·IBRO neuroscience reports

Ferulic acid via attenuation of oxidative stress and neuro-immune response utilizes antinociceptive effect in mouse model of formalin test

Article

Author: Balali-Dehkordi, Shima ; Habibian-Dehkordi, Saeid ; Amini-Khoei, Hossein ; Mohajerian, Rahil

Introduction:

Plenty evidences suggests that neuroinflammation and oxidative stress augmented the neural sensitivity specifying that neuro-immune response is involved in the pathophysiology of pain. Ferulic acid (FA), a natural antioxidant found in various fruits, has various pharmacological properties. The purpose of the current study was to assess the antinociceptive effect of FA in a mouse model of formalin test with focus on its anti-neuroinflammatory and antioxidative stress effects.

Methods:

The injection of FA (40 mg/kg), piroxicam (2 mg/kg), and saline (0.9% NaCl) (1 ml/kg) was done intraperitoneally and after one hour, formalin injected into the plantar surface of the hind paw of mice. Then pain behavior was documented during 60 min. Then mice were euthanized and prefrontal cortex (PFC) samples were taken. Malondialdehyde (MDA) level, antioxidant capacity and expression of inflammatory genes, counting tumor necrosis factor (TNF-) and interleukine 1 (IL-1) evaluated in the PFC.

Results:

exhibited that FA declined the pain behavior following injection of formalin. Besides, FA significantly diminished the MDA level and increased the antioxidant capacity in the PFC. We revealed that FA diminished the expression of TNF-α and IL-1β genes in the PFC.

Conclusion:

We conclude that FA exerted antinociceptive effects in the formalin test in mice, at least partially, by reducing oxidative stress and neuroimmune response in the PFC.

01 Mar 2024·Journal of ethnopharmacology

Aqueous extract of the bark of Uncaria tomentosa, an amazonian medicinal plant, promotes gastroprotection and accelerates gastric healing in rats

Article

Author: Mânica, Aline ; Kunst, Francine Mantelli ; de Queiroz E Silva, Thiago Farias ; Vidal Gutiérrez, Max ; Simomura, Viviane Lazari ; Somensi, Lincon Bordignon ; Miorando, Daniela ; de Oliveira, Beatriz Monteiro Magalhães ; Ansolin, Lucas Damo ; Mota da Silva, Luisa ; Buzatto, Maike Valentin ; Roman Junior, Walter Antônio ; Bohnen, Lilian Caroline ; Venzon, Larissa

ETHNOPHARMACOLOGICAL IMPORTANCE:

Uncaria tomentosa Willd. DC., is used in the Amazonian region of South America, wherein ethnic groups use the plant to treat diseases, including gastric disorders. However, despite its widespread popular use, this species has yet to be assessed for its anti-ulcer effects.

AIM OF THE STUDY:

In this study, we aimed to evaluate the in vivo gastroprotective and gastric healing activities of an aqueous extract of the bark of Uncaria tomentosa (AEUt) and sought to gain an understanding of the pharmacological mechanisms underlying these biological effects.

MATERIALS AND METHODS:

To verify the gastroprotective properties rats were treated with AEUt (30, 60, or 120 mg/kg) prior to inducing gastric ulceration with ethanol or piroxicam. Additionally, the involvement of nitric oxide, non-protein sulfhydryl compounds (NP-SH), α-2 adrenergic receptors, and prostaglandins was investigated. Furthermore, a pylorus ligature model was employed to investigate the antisecretory activity of AEUt. The gastric healing effects of AEUt (60 mg/kg) were examined in rats in which ulceration had been induced with 80% acetic acid, whereas the quality of healing was evaluated in mice with interleukin-induced recurrent ulcers. We also evaluated the in vivo thickness of the gastric wall using ultrasonography. Moreover, the levels of reduced glutathione (GSH) and malondialdehyde (MDA) were evaluated in ulcerated mucosa, and we determined the activities of the enzymes myeloperoxidase (MPO), N-acetyl-β-D-glycosaminidase, superoxide dismutase, catalase, and glutathione S-transferase. In addition, we assessed the effects of AEUt on cell viability and subjected the AEUt to phytochemical analyses.

RESULTS:

Administration of the AEUt (60 or 120 mg/kg) prevented ethanol- and piroxicam-induced ulceration, which was also confirmed histologically. Moreover, we observed that pre-treatment with NEM and indomethacin abolished the gastroprotective effects of AEUt, thereby indicating the involvement of NP-SH and prostaglandins in these protective effects. In addition, we found that the administration of AEUt had no appreciable effects on the volume, acidity, or peptic activity of gastric juice. Furthermore, the AEUt (60 mg/kg) accelerated the gastric healing of acetic acid-induced ulcers by 46.2% and ultrasonographic findings revealed a reduction in the gastric wall thickness in this group. The gastric healing effect of AEUt was also accompanied by a reduction in MPO activity. The AEUt (60 mg/kg) also minimized ulcer recurrence in mice exposed to IL-1β and was associated with the maintenance of GSH levels and a reduction in MDA contents. We deduce that the biological effects of AEUt could be associated with the activities of polyphenols and the alkaloids isomitraphylline and mitraphylline, identified as predominant constituents of the AEUt. Furthermore, we found no evidence to indicate that AEUt would have any cytotoxic effects.

CONCLUSION:

Collectively, our findings provide compelling evidence indicating the therapeutic efficacy of U. tomentosa. Our data indicate that compounds in AEUt confer gastroprotection and that this preventive effect of AEUt was accompanied by gastric healing and a reduction in gastric ulcer recurrence. Moreover, we provide evidence to indicate that the gastroprotective and gastric healing effects involve the antioxidant system and anti-inflammatory responses that contribute to preserving the gastric mucosa.

BMC pharmacology & toxicology

Drug-drug interaction assessment based on a large-scale spontaneous reporting system for hepato- and renal-toxicity, and thrombocytopenia with concomitant low-dose methotrexate and analgesics use

Article

Author: Onda, Kenji ; Honma, Takeshi ; Masuyama, Koichi

Abstract:

Background:

Methotrexate (MTX) is the cornerstone of rheumatoid arthritis (RA) treatment and is highly effective with low-dose intermittent administration. MTX is occasionally used in combination with non-steroidal anti-inflammatory drugs (NSAIDs) and acetaminophen (APAP)/paracetamol for pain or inflammation control. With MTX treatment, the side effects, such as hepatotoxicity, renal failure, and myelosuppression should be considered. These are also seen with analgesics treatment.

Methods:

We used a large spontaneously reported adverse event database (FAERS [JAPIC AERS]) to analyze whether the reporting of adverse events increased upon MTX and analgesic therapy in patients with RA.

Results:

After identifying RA cases, the crude reporting odds ratios (cRORs) for hepatotoxicity, renal failure, and thrombocytopenia associated with the use of MTX, APAP, or NSAIDs were calculated by disproportionality analysis, which revealed significantly higher cRORs for these events. No analgesics showed consistent positive signals for drug-drug interaction (DDI) with concomitant low-dose MTX analyzed using four algorithms for DDI interaction (the Ω shrinkage measure, additive or multiplicative, and combination risk ratio models). However, in renal failure and thrombocytopenia, loxoprofen (Ω025 = 0.08) and piroxicam (Ω025 = 0.46), and ibuprofen (Ω025 = 0.74) and ketorolac (Ω025 = 3.52), respectively, showed positive signals in the Ω shrinkage measure model, and no consistency was found among adverse events or NSAIDs.

Conclusions:

Studies using spontaneous reporting systems have limitations such as reporting bias or lack of patient background; however, the results of our comprehensive analysis support the results of previous clinical or epidemiological studies. This study also demonstrated the usefulness of FAERS for DDI assessment.

News (Medical) associated with Piroxicam

20 Oct 2023

·www.sciencedaily.com

Morning-after pill more effective when taken with an anti-inflammatory painkiller, researchers find

A research team recently published findings on adding an anti-inflammatory painkiller used for arthritis pain to an oral emergency contraceptive pill (also known as the morning-after pill) to increase the effectiveness of pregnancy prevention. A collaborative research team, including members of LKS Faculty of Medicine of the University of Hong Kong (HKUMed), as well as The Family Planning Association of Hong Kong (FPAHK) and Sweden's Karolinska Institutet, recently published its findings on adding an anti-inflammatory painkiller used for arthritis pain to an oral emergency contraceptive pill (also known as the morning-after pill) to increase the effectiveness of pregnancy prevention. The study was published in a recent issue of The Lancet. Background Emergency contraception is a contraceptive method that can be used to prevent an unintended pregnancy when a regular contraceptive method fails or is not used. It can be in the form of an oral emergency contraceptive pill or the insertion of a copper intrauterine contraceptive device (Cu-IUD). The oral levonorgestrel emergency contraceptive pill is one of the most popular choices of emergency contraception and is widely used in most countries. It was pioneered by a clinical trial in Hong Kong led by HKUMed's Professor Ho Pak-chung, published in 1993. However, all contraceptive methods have a failure rate. Hence, the research team is continuing its efforts to explore more effective options. Prostaglandins are substances produced by most body tissues in humans and mediate a number of biological processes, including inflammatory responses. In the reproductive system, prostaglandin is an important mediator of processes like ovulation, fertilisation and embryo implantation. The research team postulated that adding a medication that blocks prostaglandin synthesis may have an additional complementary effect in achieving contraception. Research methods and findings The research team conducted the first randomised, placebo-controlled trial in the world on the use of piroxicam, a long-acting nonsteroidal anti-inflammatory drug (NSAID) used to treat arthritis pain, which blocks prostaglandin production in the body, in combination with the levonorgestrel emergency contraceptive pill. The findings revealed that with the new combination regimen, only one out of 418 women became pregnant, while seven out of another 418 women receiving levonorgestrel and a placebo became pregnant. The results showed that the percentage of pregnancies prevented by piroxicam-levonorgestrel co-treatment (94.7%) was significantly higher than that of the levonorgestrel emergency contraceptive pill alone (63.4%). There was no significant difference in the occurrence of adverse effects, including changes to the menstrual bleeding pattern and stomach ache following intake of the two regimens. Significance of the study Chief-investigator Dr Raymond Li Hang-wun, from HKUMed, said, 'Our study is the first to find that piroxicam, a readily available medication, taken at the same time as the levonorgestrel pill can prevent more pregnancies than levonorgestrel alone. We hope these findings will lead to further research and ultimately changes in clinical guidelines to enable women around the world to access more effective emergency contraception.' Co-investigator Dr Sue Lo Seen-tsing, from FPAHK, said, 'The levonorgestrel pill was registered in Hong Kong in 2002 and has been used safely since then. Locally, emergency contraceptives must be prescribed by healthcare providers, who assess which emergency contraceptive method is the most suitable in each case. Contraceptive counselling should be provided to help women seeking emergency contraception understand that it cannot replace regular contraceptives and to motivate them to use the latter. Since there is still a small failure rate, a follow-up visit is important. The levonorgestrel emergency contraception pill should be taken within 72 hours after unprotected sex; the earlier it is taken, the more effective it is.' About the research team The study was led by Dr Raymond Li Hang-wun, Clinical Associate Professor in the Department of Obstetrics and Gynaecology, School of Clinical Medicine, HKUMed. The collaborative research team also included Professor Ho Pak-chung, Emeritus Professor, and Professor Ernest Ng Hung-yu, Clinical Professor, Department of Obstetrics and Gynaecology, School of Clinical Medicine, HKUMed; Carol Fong Ho-yi, Department of Medicine, School of Clinical Medicine, HKUMed; Dr Sue Lo Seen-tsing, The Family Planning Association of Hong Kong; and Professor Kristina Gemzell-Danielsson, Head, Department of Women's and Children's Health, Karolinska Institutet, Sweden. Acknowledgements This work was supported by research funding from the Department of Obstetrics and Gynaecology, School of Clinical Medicine, HKUMed.

Clinical ResultDrug Approval

24 Jan 2021

·www.biospace.com

Nanoform's Clinical Study Indicates Positive Interim Results - Jan 22, 2021

HELSINKI, Jan. 22, 2021 /PRNewswire/ -- Nanoform Finland Plc ("Nanoform"), an innovative nanoparticle medicine enabling company, today announced positive interim results from its clinical study. The faster absorption data implies that small particles can indeed be powerful. Nanoform has received interim study results related to its Phase 1, Single-Centre, Part Crossover, Open-Label, Partially-Randomised Study Designed to Evaluate the Pharmacokinetic (PK) Profile of Piroxicam following Administration of Nanoformed Oral Immediate Release (IR) Piroxicam Tablet and an IR Reference Product in Healthy Subjects (UNICORN). These interim results are based on the first cohort of twelve healthy volunteers dosed in December 2020 at Quotient Sciences' facilities in Nottingham, UK. Final results of the study are expected before the end of Q2 2021, as previously announced. This first set of human data supports Nanoform's value proposition that nanoparticles can enable faster dissolution rate, more rapid absorption, improve drug delivery performance, and ultimately generate patient benefit. The interim results obtained from the ongoing clinical trial, suggest that a 20 mg nanoformed oral piroxicam tablet achieved significantly faster absorption when compared to a 20 mg reference oral piroxicam tablet (Felden®) from the originator Pfizer. The time of maximum plasma concentration (T max ) was obtained earlier than with the reference product. These interim results support the further development of fast-acting forms of poorly soluble drugs by using the CESS® nanoforming technology. For further information, please contact: Prof. Edward Hæggström, CEO edward.haeggstrom@nanoform.com +358 29 370 0150 For investor relations queries, please contact: Henri von Haartman, Director of Investor Relations hvh@nanoform.com +46 7686 650 11 The information in the press release is information that Nanoform is obliged to make public pursuant to the EU Market Abuse Regulation. The information was sent for publication, through the agency of the contact persons set out above, on January 22nd, 2021 at 08:10 a.m. Finnish time. About Nanoform Nanoform is an innovative nanoparticle medicine enabling company. Nanoform works together with pharma and biotech partners globally to provide hope for patients in developing new and improved medicines utilizing Nanoform's platform technologies. The Company focuses on reducing attrition in clinical trials and on enhancing drug molecules' formulation performance through its nanoforming services. Nanoform's capabilities span the small to large molecule development space and the company focuses on solving key issues in drug solubility and bioavailability and on enabling novel drug delivery applications. Nanoform's shares are listed on the Premier-segment of Nasdaq First North Growth Market in Helsinki (ticker: NANOFH) and Stockholm (ticker: NANOFS). Certified Adviser: Danske Bank A/S, Finland Branch, +358 40 562 1806. For more information please visit Forward-Looking Statements This press release contains forward-looking statements, including, without limitation, statements regarding Nanoform's strategy, business plans and focus. The words may," "will," "could," "would," "should," "expect," "plan," "anticipate," "intend," believe," "estimate," "predict," "project," "potential," "continue," "target" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, any related to Nanoform's business, operations, clinical trials, supply chain, strategy, goals and anticipated timelines, competition from other companies, and other risks specified in Nanoform's prospectus published (on May 22, 2020) in connection with Nanoform's initial public offering (the "Prospectus") under "Risk Factors" and in our other filings or documents furnished to the Finnish Financial Supervisory Authority in connection with the Prospectus. Nanoform cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. Nanoform disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Any forward-looking statements contained in this press release represent Nanoform's views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date. This information was brought to you by Cision The following files are available for download: View original content: SOURCE Nanoform

Financial StatementIPO

100 Deals associated with Piroxicam

External Link

KEGG	Wiki	ATC	Drug Bank
D00127	Piroxicam	M02AA07 M01AC01 S01BC06	DB00554

R&D Status

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Bursitis	JP	FUJIFILM Toyama Chemical Co. Ltd.	28 Feb 2007
Myalgia	JP	Pfizer Japan, Inc.	25 Sep 1986
Periarthritis scapulohumeralis	JP	Pfizer Japan, Inc.	25 Sep 1986
Tennis Elbow	JP	Pfizer Japan, Inc.	25 Sep 1986
Tenosynovitis	JP	Pfizer Japan, Inc.	25 Sep 1986
Wounds and Injuries	JP	Pfizer Japan, Inc.	25 Sep 1986
Osteoarthritis	US	Pfizer Laboratories (Pty) Ltd.	06 Apr 1982
Rheumatoid Arthritis	US	Pfizer Laboratories (Pty) Ltd.	06 Apr 1982
Pain	CN	Jinghua Pharmaceutical Group Nantong Co. Ltd.	01 Jan 1982

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03614494 (CTgov)	Phase 2/3	Contraception	860	Levonorgestrel 1.5mg+Piroxicam 40 mg (Piroxicam)	komzrthdac(vghaeotpys) = sriewyaqtl kylbhdjxbg (yveybfnqsk, zzaluspidv - kpwatrtiuq) View more	-	06 May 2024
				Levonorgestrel 1.5mg (Placebo)	komzrthdac(vghaeotpys) = vyjuzlcazo kylbhdjxbg (yveybfnqsk, luqromjopk - khuvnptoqa) View more
NCT02450487 (CTgov)	Phase 4	-	105	Piroxicam	brsosujxpo(nufndpveie) = atozfzoiyr oxjcewxxsl (xjngqmhbwj, buredbgfof - gitztnutfv) View more	-	16 Sep 2020
ISRCTN22070974 (Pubmed \| Curr Med Res Opin)	Phase 3	Actinic Keratosis	54	ACTX	cwtlxsbdyw(diicstdwaz) = yofmkmztim qnjelfxojv (nrtceveoni ) View more	-	01 Oct 2019
EULAR2008	Not Applicable	-	-	Ibuprofen	hvdgcaspxp(fdmwfvwduu) = kxztthxsfc zgnvrnzdvp (frhcckxbjl )	-	11 Jun 2008
				Naproxen	hvdgcaspxp(fdmwfvwduu) = gvpcrsliqr zgnvrnzdvp (frhcckxbjl )
EULAR2001	Not Applicable	-	70	Tramadol/piroxicam combination	rbqafpexlr(nxgrcwcxwz) = 18% yzpkxsehvi (lljgvmmmos ) View more	-	13 Jun 2001
Pubmed	Not Applicable	Cervicobrachial syndrome \| Periarthritis scapulohumeralis	-	Piroxicam	nvguycpfzp(rbqupodnfk) = Fewer adverse reactions were observed with piroxicam jyllqtemjg (qzieihopzy ) View more	-	01 Jan 1983
				Indomethacin

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